Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot International flag

Pharmaceutical Quality (Industry), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/uv-dx-pq/ and changes regularly. See the Directory of published versions

Example Bundle: Example: Bundle - Manufacturing, substance

Bundle bundle-product-manufacturing-pq-ex2-sub of type collection


Entry 1 - fullUrl = urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265a

Resource PlanDefinition:

Generated Narrative: PlanDefinition

Resource PlanDefinition "manufacturingProcess-unlinked"

Extension - Plan Document Reference PQ: See above (DocumentReference/74d4c070-6596-8252-8ad9-afa515a41feb)

Extension - History of Process PQ: This can be text about the history

url: http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a

type: Manufacturing Process (CodeSystem - Plan Type#manufacturing-process)

status: ACTIVE

subject: See above (SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821152)

description: Narrative description of substance manufacturing process

goal

id

goal-control-pH

category: Physical Property (CodeSystem - Test Category#C123456)

description: Controls - pH ()

priority: Critical (CodeSystem - Goal Priority#critical)

Targets

-MeasureDetail[x]
*Long description of the acceptance criteria - pH must be in range 6.9 to 7.1 (CodeSystem - Example Local Codes - Drug#pH "pH")6.9-7.1 pH

goal

id

goal-control-temp

category: Physical Property (CodeSystem - Test Category#C123456)

description: Controls - Temperature ()

priority: Non-critical (CodeSystem - Goal Priority#non-critical)

Targets

-MeasureDetail[x]
*Long description of the control value - Temperature must be below 150°C (CodeSystem - Example Local Codes - Drug#TEMP "Temperature")?-150

action

code: overall process (CodeSystem - Manufacturing Step#overall process "Overall Process")

action

Extension - Process Step Scale PQ: Production Scale (Details: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStepScale-local-pq code PROD = 'Production Scale', stated as 'Production Scale')

Extension - Process Parameters PQ

url

parameter

value: Mix speed (CodeSystem - Process Parameter#SPEED)

url

value

value: 1500 rpm


Entry 2 - fullUrl = urn:uuid:82a39a18-91cf-a19d-76c1-a9e8bad9494c

Resource DeviceDefinition:

Generated Narrative: DeviceDefinition

Resource DeviceDefinition "82a39a18-91cf-a19d-76c1-a9e8bad9494c"

DeviceNames

-NameType
*Rotating Impeller with 1.5mm screenREGISTEREDNAME

Properties

-TypeValue[x]
*Maximum Speed (CodeSystem - Device Property#Maximum Speed)5000 RPM


Entry 3 - fullUrl = urn:uuid:74d4c070-6596-8252-8ad9-afa515a41feb

Resource DocumentReference:

Generated Narrative: DocumentReference

Resource DocumentReference "74d4c070-6596-8252-8ad9-afa515a41feb" Version "1" Updated "2023-01-12 17:57:08+0000"

Information Source: #n4xHiP0iat7deVDt!

identifier: http://example.org/fhir/identifier/document/FLOW-001

status: CURRENT

type: Process Flow Diagram (CodeSystem - Diagram Type#ProcessFlowDiagram)

content

Attachments

-Url
*https://example.org/docStore/flow-001


Entry 4 - fullUrl = urn:uuid:74d4c070-6596-8252-8ad9-afa515a41fef

Resource DocumentReference:

Generated Narrative: DocumentReference

Resource DocumentReference "74d4c070-6596-8252-8ad9-afa515a41fef"

status: CURRENT

content

Attachments

-Url
*https://www.accumulus.org/wp-content/uploads/2022/05/Accumulus_Logo_horizontal.png


Entry 5 - fullUrl = urn:uuid:c458791f-7cb8-428e-83f7-8a205f821152

Resource SubstanceDefinition:

Generated Narrative: SubstanceDefinition

Resource SubstanceDefinition "c458791f-7cb8-428e-83f7-8a205f821152"

manufacturer: See above (Organization/9fe98cfa-9245-8313-0fc5-d15e613b5d6d)

Names

-Name
*Stelbatolol


Entry 6 - fullUrl = urn:uuid:9fe98cfa-9245-8313-0fc5-d15e613b5d6d

Resource Organization:

Generated Narrative: Organization

Resource Organization "9fe98cfa-9245-8313-0fc5-d15e613b5d6d"

identifier: urn:oid:2.16.840.1.113883.4.82/3003040516

name: AAA Molybdenum Products, Inc.

Contacts

-Address
*7233 W 116th Pl Ste C Broomfield Colorado 80020 USA


Entry 7 - fullUrl = urn:uuid:c458791f-7cb8-428e-83f7-8a205f821153

Resource SubstanceDefinition:

Generated Narrative: SubstanceDefinition

Resource SubstanceDefinition "c458791f-7cb8-428e-83f7-8a205f821153"

manufacturer: See above (Organization/9fe98cfa-9245-8313-0fc5-d15e613b5d6d)

Names

-Name
*Stelbatosubstance


Entry 8 - fullUrl = urn:uuid:c458791f-7cb8-428e-83f7-8a205f821154

Resource SubstanceDefinition:

Generated Narrative: SubstanceDefinition

Resource SubstanceDefinition "c458791f-7cb8-428e-83f7-8a205f821154"

Names

-Name
*Resultothane


Entry 9 - fullUrl = urn:uuid:c458791f-7cb8-428e-83f7-8a205f821155

Resource SubstanceDefinition:

Generated Narrative: SubstanceDefinition

Resource SubstanceDefinition "c458791f-7cb8-428e-83f7-8a205f821155"

manufacturer: See above (Organization/9fe98cfa-9245-8313-0fc5-d15e613b5d6d)

Names

-Name
*Processohol